Unrivalled expertise from an EU Notified Body and UK Approved Body

As a manufacturer of an in vitro diagnostic (IVD) medical device, you must ensure you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are  outlined in the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 and, for the UK, the UK Medical Devices Regulations (UK MDR) 2002.

As an EU Notified Body and UK Approved Body our technical specialists have years of experience and can support you through the process of bringing your medical device on to the market.

Dedicated training courses

At BSI we offer training courses tailored to In-Vitro Diagnostics to help support and grow your business.

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